Summary of safety events (all causality) up to months 3 and 12 for patients receiving tofacitinib 5 mg two times per day, 10 mg two times per day and placebo, by sex*; pooled data from OPAL Broaden and OPAL Beyond
| Up to month 3 | Tofacitinib 5 mg two times per day | Tofacitinib 10 mg two times per day | Placebo | |||
| Patients with events, n (%) | Male (N=117) | Female (N=121) | Male (N=100) | Female (N=136) | Male (N=100) | Female (N=136) |
| TEAEs | 55 (47.0) | 59 (48.8) | 44 (44.0) | 73 (53.7) | 30 (30.0) | 65 (47.8) |
| SAEs | 2 (1.7) | 2 (1.7) | 3 (3.0) | 1 (0.7) | 0 | 4 (2.9) |
| Discontinuation due to AEs | 1 (0.9) | 2 (1.7) | 2 (2.0) | 5 (3.7) | 3 (3.0) | 1 (0.7) |
| Deaths | 0 | 0 | 0 | 0 | 0 | 0 |
| Serious infections | 0 | 0 | 1 (1.0) | 1 (0.7) | 0 | 0 |
| HZ (serious and non-serious)† | 1 (0.9) | 1 (0.8) | 0 | 1 (0.7) | 0 | 0 |
| OIs (excluding TB) | 1 (0.9)‡ | 0 | 0 | 0 | 0 | 0 |
| TB | 0 | 0 | 0 | 0 | 0 | 0 |
| MACE | 0 | 0 | 0 | 0 | 0 | 0 |
| Malignancies (excluding NMSC) | 1 (0.9) | 1 (0.8) | 0 | 0 | 0 | 0 |
| NMSC | 0 | 0 | 0 | 0 | 0 | 0 |
| GI perforations | 0 | 0 | 0 | 0 | 0 | 0 |
| VTEs | 0 | 0 | 0 | 0 | 0 | 0 |
| Up to month 12 | Tofacitinib 5 mg two times per day | Tofacitinib 10 mg two times per day | ||||
| Patients with events, n (%) | Male (N=117) | Female (N=121) | Male (N=100) | Female (N=136) | ||
| TEAEs | 79 (67.5) | 85 (70.2) | 70 (70.0) | 99 (72.8) | ||
| SAEs | 4 (3.4) | 8 (6.6) | 4 (4.0) | 8 (5.9) | ||
| Discontinuation due to AEs | 3 (2.6) | 8 (6.6) | 4 (4.0) | 7 (5.1) | ||
| Deaths | 0 | 0 | 0 | 0 | ||
| Serious infections | 0 | 2 (1.7) | 1 (1.0) | 2 (1.5) | ||
| HZ (serious and non-serious)† | 1 (0.9) | 2 (1.7) | 2 (2.0) | 2 (1.5) | ||
| OIs (excluding TB)§ | 1 (0.9)‡ | 0 | 0 | 0 | ||
| TB | 0 | 0 | 0 | 0 | ||
| MACE¶ | 0 | 0 | 0 | 1 (0.7) | ||
| Malignancies (excluding NMSC) | 1 (0.9) | 2 (1.7) | 0 | 0 | ||
| NMSC | 0 | 0 | 1 (1.0) | 0 | ||
| GI perforations | 0 | 0 | 0 | 0 | ||
| VTEs | 0 | 0 | 0 | 0 | ||
*Includes all patients from OPAL Broaden and OPAL Beyond who were randomised at baseline to tofacitinib 5 mg two times per day, 10 mg two times per day or PBO.
†No serious events of HZ were reported in males or females receiving tofacitinib 5 mg or 10 mg two times per day.
‡Moderate HZ (three dermatomes affected).
§One adjudicated OI (multidermatomal HZ, two adjacent dermatomes) occurring in a female patient receiving tofacitinib 5 mg two times per day in OPAL Broaden was reclassified as a ‘Special Interest Infection’ and included in HZ (serious and non-serious).
¶One MACE was reported in a male patient receiving tofacitinib 5 mg two times per day outside the 28-day risk period.
AEs, adverse events; GI, gastrointestinal; HZ, herpes zoster; MACE, major adverse cardiovascular events; N, number of patients included in the analysis; n, number of patients with the event (events are counted up to 28 days beyond the last dose or the end of month 3 or month 12); NMSC, non-melanoma skin cancer; OIs, opportunistic infections; PBO, placebo; SAEs, serious adverse events; TB, tuberculosis; TEAEs, treatment-emergent adverse events; VTEs, venous thromboembolic events.